Clinical Trial: The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of an Oral Antioxidant, N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis

Brief Summary: This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis.

Detailed Summary: Sarcoidosis is a granulomatous lung disease predominantly affecting the lungs. Reactive oxidative species are produced secondary to oxidative stress and inflammation and can affect key cellular processes. The investigators have shown a role for oxidative stress in chronic beryllium disease (CBD), a granulomatous disease that resembles sarcoidosis, and have also shown that antioxidant therapy reduces inflammation in CBD. Oxidative stress also plays a role in sarcoidosis but the exact mechanism and potential effect of antioxidant therapy on sarcoidosis is unknown. The investigators propose conducting a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis. The investigators will measure and compare markers of inflammation and oxidative stress in the lungs of sarcoidosis patients before and after treatment with NAC. The results of this study will prepare the investigators for a larger study investigating the role of NAC as a therapy for sarcoidosis with changes in lung function and x-ray as our primary outcome. This will provide the investigators with a new non-toxic therapy for sarcoidosis that can be used on its own or to supplement other therapies minimizing their toxicity.
Sponsor: National Jewish Health

Current Primary Outcome: Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels [ Time Frame: 8 weeks of anti-oxidant therapy ]

Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml)


Original Primary Outcome: Effect of an oral anti-oxidant on lung inflammation [ Time Frame: change in lung inflammation after 8 weeks of anti-oxidant therapy ]

Association of oxidative stress with inflammatory markers in the lungs of sarcoidosis patients and the effect of an 8 week course of an oral anti-oxidant on the levels of oxidative stress and inflammation.


Current Secondary Outcome: Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels [ Time Frame: 8 weeks of anti-oxidant therapy ]

We measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo.


Original Secondary Outcome: Effect of an oral anti-oxidant on lung oxidative stress [ Time Frame: change in lung oxidative stress after 8 weeks of anti-oxidant therapy ]

Association of oxidative stress with inflammatory markers in the lungs of sarcoidosis patients and the effect of an 8 week course of an oral anti-oxidant on the levels of oxidative stress and inflammation.


Information By: National Jewish Health

Dates:
Date Received: January 10, 2012
Date Started: November 2011
Date Completion:
Last Updated: March 27, 2017
Last Verified: March 2017